Liver Cancer Disparities in American Indian and Alaska Native Persons
2 other identifiers
interventional
200
1 country
1
Brief Summary
We are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hepatocellular-carcinoma
Started Apr 2022
Typical duration for phase_2 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedJune 4, 2024
June 1, 2024
3.4 years
March 22, 2022
June 3, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Compliance with screening protocol
Compliance with conducting all three screening tests
12 months
Feasibility of screening protocol
Proportion of screening tests conducted that employed the appropriate screening protocol and used appropriate documentation of findings with the LI-RADS system
12 months
Study Arms (2)
Ultrasound + AFP
ACTIVE COMPARATORScreening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months
aMRI + AFP
ACTIVE COMPARATORScreening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months
Interventions
Abdominal ultrasound or abbreviated MRI
Eligibility Criteria
You may qualify if:
- Cirrhosis, any etiology, or chronic HBV infection
- High risk of HCC
- Age 18-75
- Competent to provide informed consent
You may not qualify if:
- Prior diagnosis of HCC
- Current suspicion of HCC
- Prior receipt of any organ transplantation
- Participation in another HCC screening trial
- CTP score \>=10
- MELD-Na score \>20
- GFR\<30
- Poor life expectancy (\<5 years)
- Contraindication to MRI
- Inability to complete study visits
- Currently pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- National Cancer Institute (NCI)collaborator
- Cherokee Nation Health Servicescollaborator
- Alaska Native Tribal Health Consortiumcollaborator
Study Sites (1)
Cherokee Nation Health Service
Tahlequah, Oklahoma, 74464, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George Ioannou, MD, MS
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, School of Medicine, Gastroenterology
Study Record Dates
First Submitted
March 22, 2022
First Posted
March 31, 2022
Study Start
April 1, 2022
Primary Completion
September 1, 2025
Study Completion (Estimated)
September 1, 2026
Last Updated
June 4, 2024
Record last verified: 2024-06